NCT00336011

Brief Summary

To evaluate short-term and long-term effects by MR imaging on the technical and functional status of Medtronic pacemakers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2002

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2002

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 12, 2006

Completed
Last Updated

June 12, 2006

Status Verified

January 1, 2006

First QC Date

June 9, 2006

Last Update Submit

June 9, 2006

Conditions

Heart Diseases

Keywords

pacemakermagnetic resonance imagingsafety

Interventions

Magnetic resonance imagingDEVICE

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Urgent need for an MRI examination
  • Presence of a Medtronic PM system manufactured between 1993 and 2004
  • Stable pacemaker physical parameters
  • Battery voltage \> 2.7 V
  • Battery impedance \< 2000 Ohm
  • Battery estimated remaining lifetime \> 6 months
  • Lead impedances 200-2000 Ohm
  • Stable pacing parameters
  • Pacing capture threshold \<2.5V at a pulse duration of 0.4ms
  • Sensing \> 5mV
  • Minimum 3 months since pacemaker and lead implantation

You may not qualify if:

  • PM system manufacturer other than Medtronic
  • History of ventricular tachycardia (VT) or ventricular fibrillation
  • Unstable angina
  • Myocardial infarction within the previous 3 months
  • Cardiothoracic surgery within the previous 3 months
  • Complete atrioventricular block
  • Absolute pacemaker dependence
  • Heart rate \< 40 bpm or
  • Heart rate \< 60 bpm producing neurological symptoms
  • Presence of an abdominal pacemaker with lead length \> 70 cm
  • Presence of MRI incompatible bioimplants or other MRI incompatible materials
  • Request for an MR examination of the chest, including the heart, breasts and thoracic spine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bonn, Department of Radiology

Bonn, North Rhine-Westphalia, 53127, Germany

Location

MeSH Terms

Conditions

Heart Diseases

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Torsten Sommer, MD

    University of Bonn, Department of Radiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 9, 2006

First Posted

June 12, 2006

Study Start

December 1, 2002

Study Completion

January 1, 2006

Last Updated

June 12, 2006

Record last verified: 2006-01

Locations

DE(1)